1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

2

1. NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

Each 2.5 ml single dose vial contains 185 MBq ioflupane (123I) (specific activity range 2.5 to

4.5 x 1014 Bq/mmol) at reference time.

Each 5 ml single dose vial contains 370 MBq ioflupane (123I) (specific activity range 2.5 to

4.5 x 1014 Bq/mmol) at reference time.

Excipient(s) with known effect

This medicinal product contains 39.5 g/l ethanol.

For the full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear colourless solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

• In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early

symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related

to idiopathic Parkinson’s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.

DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and

Progressive Supranuclear Palsy.

• In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s

disease.

DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease

dementia.

4.2 Posology and method of administration

Prior to administration appropriate resuscitation equipment should be available.

DaTSCAN should only be used in adult patients referred by physicians experienced in the management

of movement disorders and/or dementia. DaTSCAN should only be used by qualified personnel with the

appropriate government authorisation for the use and manipulation of radionuclides within a designated

clinical setting.

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Posology

Clinical efficacy has been demonstrated across the range 111 to 185 MBq. Do not exceed 185 MBq and

do not use when the activity is below 110 MBq.

Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid

uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium

iodide 1 to 4 hours prior to injection of DaTSCAN.

Special populations

Renal and hepatic impairment

Formal studies have not been carried out in patients with significant renal or hepatic impairment. No

data are available (see section 4.4).

Paediatric population

The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established. No data

are available.

Method of Administration

For intravenous use.

DaTSCAN should be used without dilution. To minimise the potential for pain at the injection site

during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is

recommended.

SPECT imaging should take place between three and six hours post-injection. Images should be

acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the

159 keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than

120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent

and set as small as possible (typically 11-15cm). Experimental studies with a striatal phantom, suggest

that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of

3.5-4.5 mm for those systems currently in use. A minimum of 500k counts should be collected for

optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal

intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of

crescent.

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

- Pregnancy (see section 4.6).

4.4 Special warnings and precautions for use

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued

immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and

equipment (e.g. endotracheal tube and ventilator) have to be readily available.

This radiopharmaceutical may be received, used and administered only by authorised persons in

designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations

and the appropriate licences of the local competent official organisations.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The

activity administered must be such that the resulting dose is as low as reasonably achievable bearing in

mind the need to obtain the intended diagnostic result.

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Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the

absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic

impairment.

This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose,

equivalent to 5 ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into

account in high-risk groups such as patients with liver disease or epilepsy.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed in humans.

Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high

affinity may therefore interfere with DaTSCAN diagnosis. These include amfetamine, benzatropine,

buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.

Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine,

trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine

agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere

with DaTSCAN imaging and can therefore be continued if desired. Medicinal products shown in animal

studies not to interfere with DaTSCAN imaging include pergolide.

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

Where it is necessary to administer radioactive medicinal products to women of childbearing potential,

information should always be sought about pregnancy. Any woman who has missed a period should be

assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation

exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques

which do not involve ionising radiation should be considered.

Pregnancy

Animal reproductive toxicity studies have not been performed with this product. Radionuclide

procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of

185 MBq of ioflupane (123I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is

contraindicated in pregnancy (see section 4.3).

Breastfeeding

It is not known whether ioflupane (123I) is excreted in human milk. Before administering a radioactive

medicinal product to a breast-feeding mother, consideration should be given as to whether the

investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether

the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of

radioactivity in breast milk. If administration is considered necessary, breast-feeding should be

interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be

expressed at regular intervals and the expressed feeds should be discarded.

Fertility

No fertility studies have been performed. No data are available.

4.7 Effects on ability to drive and use machines

DaTSCAN has no known influence on the ability to drive and use machines.

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4.8 Undesirable effects

The following undesirable effects are recognised for DaTSCAN:

Tabulated summary of adverse reactions

The frequencies of adverse reactions are defined as follows:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available

data). Within each frequency grouping, undesirable effects are presented in order of decreasing

seriousness.

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Uncommon: Appetite increased

Nervous system disorders

Common: Headache

Uncommon: Dizziness, formication (paraesthesia), dysgeusia

Ear and labyrinth disorders

Uncommon: Vertigo

Skin and subcutaneous tissue disorders

Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis

Respiratory, thoracic and mediastinal disorders

Not known: Dyspnea

Gastrointestinal disorders

Uncommon: Nausea, dry mouth

Not known: Vomiting

Vascular disorders

Not known: Blood pressure decreased

General disorders and administration site conditions

Uncommon: Injection site pain (intense pain or burning sensation following administration into small

veins)

Not known: Feeling hot

Exposure to ionising radiation is linked with cancer induction and a potential for development of

hereditary defects. As the effective dose is 4.63 mSv when the maximal recommended activity of

185 MBq is administered these adverse events are expected to occur with a low probability.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.

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4.9 Overdose

In cases of overdose of radioactivity, frequent micturition and defaecation should be encouraged in

order to minimise radiation dose to the patient. Care should be taken to avoid contamination from the

radioactivity eliminated by the patient using such methods.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system,

ATC code: V09AB03.

Due to the low quantities of ioflupane injected, pharmacological effects are not expected following

intravenous administration of DaTSCAN at the recommended dosage.

Mechanism of action

Ioflupane is a cocaine analogue. Studies in animals have shown that ioflupane binds with high affinity to

the presynaptic dopamine transporter and so radiolabelled ioflupane (123I) can be used as a surrogate

marker to examine the integrity of the dopaminergic nigrostriatal neurons. Ioflupane also binds to the

serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.

There is no experience in types of tremor other than essential tremor.

Clinical efficacy

Clinical studies in patients with dementia with Lewy bodies

In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB)

(144 subjects), Alzheimer’s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects),

the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the

clinical diagnosis as determined by physicians experienced in the management and diagnosis of

dementias. Clinical categorisation into the respective dementia group was based on a standardised and

comprehensive clinical and neuropsychiatric evaluation. The values for the sensitivity of DaTSCAN in

determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to

91.4%. The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value

from 86.1% to 88.7%. Analyses in which both possible and probable DLB patients were compared with

non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0%

to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as

non-DLB patients. The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4%

when the possible DLB patients were included as DLB patients.

5.2 Pharmacokinetic properties

Distribution

Ioflupane (123I) is cleared rapidly from the blood after intravenous injection; only 5% of the

administered activity remains in whole blood at 5 minutes post-injection.

Organ uptake

Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and

decreasing to 3% after 5 hours. About 30% of the whole brain activity is attributed to striatal uptake.

Elimination

At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with

faecal excretion calculated at approximately 14%.

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5.3 Preclinical safety data

Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of

safety pharmacology, single and repeated dose toxicity and genotoxicity.

Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been

performed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acetic acid

Sodium acetate

Ethanol

Water for injections

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

2.5 ml vial: 7 hours from the activity reference time stated on the label.

5 ml vial: 20 hours from the activity reference time stated on the label.

6.4 Special precautions for storage

Do not store above 25oC. Do not freeze.

6.5 Nature and contents of container

2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal

overseal.

Pack size of 1.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

General warning

Normal safety precautions for handling radioactive materials should be observed.

Disposal

After use, all materials associated with the preparation and administration of radiopharmaceuticals,

including any unused product and its container, should be decontaminated or treated as radioactive

waste and disposed of in accordance with the conditions specified by the local competent authority.

Contaminated material must be disposed of as radioactive waste via an authorised route.

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7. MARKETING AUTHORISATION HOLDER

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

8. MARKETING AUTHORISATION NUMBERS

EU/1/00/135/001 (2.5 ml)

EU/1/00/135/002 (5 ml)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27 July 2000

Date of latest renewal: 28 July 2010

10. DATE OF REVISION OF THE TEXT

11 DOSIMETRY

Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant

energy of 159 keV and X-rays of 27 keV.

The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of

ioflupane (123I) are listed in the Table below. The values are calculated assuming urinary bladder

emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron

emitter). Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.

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Target Organ Absorbed radiation dose

Gy/MBq

Adrenals

Bone surface

Brain

Breast

Gallbladder wall

Gastrointestinal tract

Stomach wall

Small intestine wall

Colon wall

(Upper large intestine wall

(Lower large intestine wall

Heart wall

Kidneys

Liver

Lungs

Muscles

Oesophagus

Ovaries

Pancreas

Red marrow

Salivary glands

Skin

Spleen

Testes

Thymus

Thyroid

Urinary bladder wall

Uterus

Remaining organs

17.0

15.0

16.0

7.3

44.0

12.0

26.0

59.0

57.0)

62.0)

32.0

13.0

85.0

42.0

8.9

9.4

18.0

17.0

9.3

41.0

5.2

26.0

6.3

9.4

6.7

35.0

14.0

10.0

Effective Dose (µSv/MBq) 25.0

Ref.: Publication 128 of the Annals of ICRP (Radiation dose to Patients from Radiopharmaceuticals: A Compendium

of Current Information Related to Frequently Used Substances, 2015

The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.63 mSv

(per 70 kg individual). The above data are valid in normal pharmacokinetic behaviour. When renal or

hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be

increased.

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements. See also section 6.6.

Detailed information on this medicinal product is available on the website of the European Medicines

Agency http://www.ema.europa.eu

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ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND

USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE

MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

B. CONDITIONS OR RESTRICTIONS REARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product

Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

AUTHORISATION

• Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out

in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive

2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE

USE OF THE MEDICINAL PRODUCT

Not applicable

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ANNEX III

LABELLING AND PACKAGE LEAFLET

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A. LABELLING

14

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

5 ml presentation

1. NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection.

Ioflupane (123I)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

3. LIST OF EXCIPIENTS

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP: 20 h post-ref.

Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY

9. SPECIAL STORAGE CONDITIONS

Do not store above 25C.

Do not freeze.

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

APPROPRIATE

Handling and disposal – see package leaflet.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/135/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS FOR USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

Not applicable

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

5 ml presentation

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DaTSCAN 74 MBq/ml solution for injection.

Ioflupane (123I)

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP: 20 h post-ref.

Ref.: 370 MBq/5 ml ioflupane (123I) at 2300 CET on DD/MM/YYYY.

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

2.5 ml presentation

1. NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

3. LIST OF EXCIPIENTS

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP: 7 h post-ref.

Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY

9. SPECIAL STORAGE CONDITIONS

Do not store above 25C.

Do not freeze.

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

APPROPRIATE

Handling and disposal – see package leaflet.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/135/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS FOR USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

Not applicable

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

2.5 ml presentation

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP: 7 h post-ref.

Ref.: 185 MBq/2.5 ml ioflupane (123I) at 1200 CET on DD/MM/YYYY

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

6. OTHER

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

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B. PACKAGE LEAFLET

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Package leaflet: Information for the user

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your nuclear medicine doctor who will supervise the

procedure.

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What DaTSCAN is and what it is used for

2. What you need to know before DaTSCAN is used

3. How DaTSCAN is used

4. Possible side effects

5. How DaTSCAN is stored

6. Contents of the pack and other information

1. What DaTSCAN is and what it is used for

DaTSCAN contains the active substance ioflupane (123I) which is used to help identify (diagnose)

conditions in the brain. It belongs to a group of medicines called “radiopharmaceuticals”, which contain

a small amount of radioactivity.

• When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a

short time.

• Because it contains a small amount of radioactivity it can be detected from outside the body using

special cameras.

• A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is

inside the organ and the body. This can give the doctor valuable information about how that organ

is working.

When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small

area of your brain. Changes in this area of the brain occur in:

• Parkinsonism (including Parkinson’s disease) and

• dementia with Lewy bodies.

A scan will give your doctor information about any changes in this area of your brain. Your doctor may

feel that the scan would help in finding out more about your condition and deciding on possible

treatment.

When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than

in some types of X-ray investigation. Your doctor and the nuclear medicine doctor have considered that

the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed

to these small amounts of radiation.

This medicine is used for diagnostic use only. It is used only to identify illness.

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2. What you need to know before DaTSCAN is used

DaTSCAN must not be used

• if you are allergic to ioflupane or any of the other ingredients of this medicine (listed in section 6).

• if you are pregnant

Warnings and precautions

Talk to your nuclear medicine doctor before using DaTSCAN if you have a moderate or severe problem

with your kidneys or liver.

Children and adolescents

DaTSCAN is not recommended for children aged 0 to 18 years

Other medicines and DaTSCAN

Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines.

Some medicines or substances can affect the way that DaTSCAN works.

These include:

• buproprion (used to treat depression (sadness))

• benzatropine (used to treat Parkinson’s disease)

• mazindol (reduces appetite, as a means to treat obesity)

• sertraline (used to treat depression (sadness))

• methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))

• phentermine (reduces appetite, as a means to treat obesity)

• amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a

drug of abuse)

• cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse)

Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking

them for a short time before you receive DaTSCAN.

Pregnancy and breast-feeding

Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the

child may receive some of the radioactivity. Tell your nuclear medicine doctor if you think you might be

pregnant. Alternative techniques which do not involve radioactivity should be considered.

If you are breast-feeding, your nuclear medicine doctor may delay the use of DaTSCAN, or ask you to

stop breast-feeding. It is not known whether ioflupane (123I) is passed into breast milk.

• You should not breast-feed your child for 3 days after DaTSCAN is given.

• Instead use formula feed for your child. Express your breast milk regularly and throw away any

breast milk you have expressed.

• You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.

Driving and using machines

DaTSCAN has no known influence on the ability to drive and use machines.

DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is

about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism and needs

to be taken into account in pregnant or breastfeeding women, children and high risk groups such as

patients with liver disease or epilepsy. Tell your doctor if any of these apply to you.

3. How DaTSCAN is used

There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN will always be used

in a hospital or a similar place. It will only be handled and given to you by people who are trained and

qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine.

23

Your nuclear medicine doctor will decide the dose that is best for you.

Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquid

that contain iodine. These stop the radioactivity building-up in your thyroid gland. It is important that

you take the tablets or liquid as the doctor tells you.

DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended

radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to

measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours

after the injection of DaTSCAN.

If you are given more DaTSCAN than you should

Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an

overdose. Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get

rid of the medicine. You will need to be careful with the water (urine) that you pass - your doctor will tell

you what to do. This is normal practice with medicines like DaTSCAN. Any ioflupane (123I) which

remains in your body will naturally lose its radioactivity.

If you have any further questions on the use of this medicine, ask your nuclear medicine doctor who

supervises the procedure.

4. Possible side effects

Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.

The frequency of side effects is:

Common: may affect up to 1 in 10 people

- Headache

Uncommon: may affect up to 1 in 100 people

- Increased appetite

- Dizziness

- Taste disturbance

- Nausea

- Dry mouth

- Vertigo

- A brief irritating feeling similar to ants crawling over your skin (formication)

- Intense pain (or burning sensation) at the injection site. This has been reported among

patients receiving DaTSCAN into a small vein.

Not known: frequency cannot be estimated from the available data.

- Hypersensitivity (allergic)

- Shortness of breath

- Redness of the skin

- Itching

- Rash

- Hives (urticaria)

- Excessive sweating

- Vomiting

- Low blood pressure

- Feeling hot

The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body

in a few days without need for you to take special precautions.

24

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

5. How DaTSCAN is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist

in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation

on radioactive materials.

The following information is intended for the specialist only:

• Keep this medicine out of the sight and reach of children.

• Do not store above 25C.

• Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The

expiry date refers to the last day of that month. Hospital staff will ensure that the product is stored and

thrown away correctly and not used after the expiry date stated on the label.

6. Contents of the pack and other information

What DaTSCAN contains

• The active substance is ioflupane (123I). Each ml of solution contains ioflupane (123I) 74 MBq at

reference time (0.07 to 0.13 μg/ml of ioflupane).

• The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.

What DaTSCAN looks like and contents of the pack

DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass

vial sealed with a rubber closure and metal overseal.

Marketing Authorisation Holder and Manufacturer

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

GE Healthcare BVBA

Tél/Tel: +32 (0) 2 719 7410

Lietuva

General Electric International Inc.

Tel.: +370 68 726 753

България

GE Healthcare Bulgaria EOOD

Teл: +359 2 9712561

Luxembourg/Luxemburg

GE Healthcare BVBA

België/Belgique/Belgien

Tél/Tel: +32 (0) 2 719 7410

25

Česká republika

M.G.P. spol. s r.o.

Tel.: +420 577 212 140

Magyarország

Radizone Diagnost-X Kft.

Tel: +36 1 787-5720

Danmark

GE Healthcare A/S

Tlf: +45 70 2222 03

Malta

Pharma-Cos Ltd.

Tel: +356 21441 870

Deutschland

GE Healthcare Buchler GmbH & Co. KG

Tel: +49 (0) 5 307 93 00

Nederland

GE Healthcare B.V.

Tel: +31 (0) 40 299 10 00

Eesti

GE Healthcare Estonia OÜ

Tel: +372 6260 061

Norge

GE Healthcare AS

Tlf: +47 23 18 50 50

Ελλάδα

GE Healthcare A.E.

Τηλ: +30 210 8930600

Österreich

GE Healthcare Handels GmbH

Tel: +43 (0) 1 97272-0

España

GE Healthcare Bio-Sciences, S.A.U

Tel: +34 91 663 25 00

Polska

GE Medical Systems Polska Sp. z o.o.

Tel: +4822 330 83 00

France

GE Healthcare SAS

Tél: +33 1 34 49 54 54

Portugal

Satis – GE Healthcare

Tel: +351 214251352

Hrvatska

GE Healthcare d.o.o.

Tel: +385 (0)1 61 70 280

România

S.C. GENERAL ELECTRIC MEDICAL

SYSTEMS ROMANIA S.R.L.

Tel. +40 37 2074527

Ireland

GE Healthcare Limited

UK

Tel: +44 (0) 1494 54 40 00

Slovenija

Biomedis M.B. trgovina d.o.o.

Tel: +386 2 4716300

Ísland

Icepharma

Sími: + 354 540 8000

Slovenská republika

MGP, spol. s r. o.

Tel: +421 2 5465 4841

Italia

GE Healthcare S.r.l.

Tel: +39 02 26001 111

Suomi/Finland

Oy GE Healthcare Bio-Sciences Ab

Puh/Tel: +358 10 39411

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

GE Healthcare AB

Tel: +46 (0) 8 559 504 00

Latvija

General Electric International Inc.

Tel: +371 6780 7086

United Kingdom

GE Healthcare Limited

Tel: +44(0)1494 544000

26

This leaflet was last revised in <{MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site;

http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.